Vascular sealing apparatus

ABSTRACT

A device for sealing an opening or puncture in the wall of a blood vessel or other percutaneous openings. The device includes a shaft section member of a small diameter, with an expandable balloon and atraumatic tip at its distal end. The proximal end of the device has an inflation/deflation port which is utilized to inflate the balloon once it is in place within the blood vessel or other body cavity. The entire device is placed through a hemostasis vascular introducer or sheath, which is used during invasive percutaneous vascular procedures. The balloon is inflated and withdrawn until it engages the inner surface of the blood vessel. A procoagulant is injected via the introducer to the puncture. After a predetermined time period, the balloon is deflated and the device is withdrawn.

This is a Continuation of application Ser. No. 08/549,430 filed Oct. 27,1995, abandoned which in turn is a continuation-in-part of applicationSer. No. 08/303,088, filed Sep. 8, 1994 abandoned which is acontinuation of application Ser. No. 67,213, filed May 25, 1993, nowU.S. Pat. No. 5,383,896, issued Jan. 24, 1995.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical devices in general and, moreparticularly, to hemostatic devices. The device is particularly usefulfor arresting the flow of blood or hemorrhage from punctures of thevascular system.

2. Background Art

Various surgical procedures are performed by medical specialists such ascardiologists, utilizing percutaneous entry into a blood vessel or bodycavity. Examples of such procedures include different techniques torecanalize atherosclerotic blood vessels, such as balloon angioplasty oratherectomy. Recently, both the types and number of procedures performedutilizing the above mentioned percutaneous access to blood vessels haveincreased greatly.

These procedures generally involve the percutaneous puncture with a thinwalled needle into a blood vessel. Following this, a guidewire is placedthrough the needle into the blood vessel and the needle is withdrawn. Anintravascular sheath of variable size is then advanced over theguidewire, percutaneously, into the lumen of the blood vessel. Theintroducer sheath is then used as an ingress/egress means during theprocedure. Following completion of the procedure, the introducer sheathmay be removed, but this requires the application of prolonged manualpressure over the puncture site by a physician or other suitably trainedmedical personnel. The time involved here is frequently extensive sincepatients are often treated with a variety of anticoagulant andthrombolytic agents, particularly in the setting of a heart attack.Alternatively, the sheath may be left in the puncture site for aprolonged period of time until the patient's coagulation status hasreturned to normal. Depending on the size of the vascular sheath, theremay be an increased risk of bleeding to the patient, which may requireblood transfusion. In addition, there is a significant risk for injuryto the blood vessel upon removal of the sheath, particularly if thesheath has been in place for a prolonged period of time. This includesthe possible development of an pseudo-aneurysm or severe hematoma. Thecurrent technique for removal of introducer sheaths is also painful tothe patient and requires prolonged bed rest after removal. This adds tothe discomfort for the patient, as well as prolonging hospitalizationand costs.

Many of the intra-vascular procedures are performed in patients who areclinically unstable or who have the potential to become so, followingcompletion of the procedure. Following removal of the vascular accesssheath, it could be cumbersome and sometimes difficult to re-enter theblood vessel if necessary. Thus, with the current technique for removalof the sheath following the procedure, no easy, reliable method isavailable to allow reaccess to the lumen of the blood vessel, ifnecessary.

In the past, various devices and methods have been used and proposed inan attempt to seal punctures in blood vessels by injection of aresorbable hemostatic plug into the puncture site, including U.S. Pat.No. 4744364(Kensey), U.S. Pat. No. 4852568(Kensey), and U.S. Pat. No.4890612(Kensey).

Despite the need for a device and method which overcome the limitationsand problems of the prior art, none insofar as is known, has beenproposed or developed.

SUMMARY OF THE INVENTION

This invention provides a device for sealing an opening or puncture inthe wall of a blood vessel. The device includes a shaft section of smalldiameter, with an expandable balloon and guidewire tip at its distalend. The proximal end of the device has a low profile port which isutilized to inflate and deflate the distal balloon once it is in placewithin the blood vessel, and which permits removal of a standardhemostasis introducer which is preexisting in the puncture. Theintroducer is used to inject a procoagulant to the puncture site,proximally with respect to the balloon for sealing.

Unique aspects of this invention include: (1) the creation of immediatehemostasis at the puncture site for procoagulant delivery; (2) thedevice balloon acts as a marker for delivery of procoagulant; (3)balloon approach prevents injection of procoagulant into thebloodstream; and (4) the apparatus and method allow reaccess to thepatient's vasculatlire. Other features, benefits and objects of thisinvention will become clear from the following description by referenceto the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a vascular sealing device of the presentinvention, with segments enlarged to show details of the distal andproximal ends thereof

FIG. 2 is a view of the vascular sealing device inserted through anintroducer sheath and into a patient's vascular system, which is shownenlarged and in section.

FIG. 3 is a view of the vascular sealing device inserted through avascular sheath, and being inflated.

FIG. 4 is a view of the vascular sealing device with its balloon portioninflated, and further showing removal of the vascular sheath.

FIG. 5 is a view of the vascular sealing device with the ballooninflated and being pulled firmly up against the inner surface of avascular puncture.

FIG. 6 is a crossectional view of the apparatus taken along line 6--6 ofFIG. 1a.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1 and 6, a preferred form is shown of the vascularsealing device 10 for effecting closure of a puncture in a blood vesselwhich has been entered through percutaneous techniques. The device 10 isuseable with a procoagulant which is injected through a standardpercutaneous vascular sheath or introducer. The vascular sealing device10 is shown to have an elongated thin, generally tubular body or conduit15 with proximal and distal ends 11 and 12, respectively. Basically, theproximal end 11 of the device 10 is for physician manipulation andconnection to associated medical apparatus described further below,while the distal end 12 is for insertion into the patient's body.Located at the proximal end 11 of device 10 is an inflation/deflationport 14.

The body member 15 has a tubular structure constructed of hypotubing ora similar material. This structure also has a cylindrical and thin outerbody wall with a central, continuous, and longitudinally extending lumen28. The body member 15 has an outside diameter preferably not greaterthan 0.038 inches (0.965 mm.). The body 15 is semiflexible and,importantly, has a predetermined rigidity such that central lumen 28integrity is maintained. This is particularly important duringlongitudinal translational manipulation by the physician, throughvascular introducer means (described below), into a percutaneouspuncture in the patient's skin. The hypotubing of the body 15 ispreferably constructed of a metallic material such as stainless steel,for example. Alternatively, the body 15 may be constructed of apolymeric material. The body member 15 is shown to have a lengthpreferably of at least 11.79 inches (30 cm).

The proximal end 11 of the lumen or hollow interior 28 is sealed withelastomeric material, preferably silicone, to form aninflation/deflation port 14. The seal forms the inflation/deflation port14 by adhering to the internal wall surfaces of the proximal end 11 ofbody 15. The seal is of sufficient strength to maintain a pressuredifference between the internal lumen 28 and the proximally disposedexterior of the seal. This pressure difference is of a magnitudesufficient to maintain inflation of the balloon 34, which is incontinuity with the lumen 28. The inflation/deflation port 14 isutilized by piercing its proximal face, preferably with a syringeneedle, to a depth which allows the needle lumen to be in continuitywith the lumen 28. An external syringe, attached to the proximal end ofthe needle, provides a piston means by which a gas or liquid is pumpedinto the balloon 34 for inflation, or out of the balloon 34 fordeflation. Removal of the needle from the inflation/deflation port 14causes the seal to reestablish the pressure differential barrier.

The structure of the proximal end 11 also allows the user to later slidea standard vascular sheath over the device body 15 and then to advanceit to the puncture site for positioning within the blood vessel lumen.This allows reentry into the blood vessel, if necessary, for a furtherinterventional procedure.

The bottom or distal end 12 of the device body 15 is shown to have adistal tip 29. The distal tip 29 further has an inset segment 32. Theinset segment 32 has a tubular configuration and is oriented coaxiallywith respect to the distal tip 29. The inset segment 32 preferably has adiameter which is less than that of the distal tip 29 and a lengthequivalent to that of the wall of the balloon 34 when deflated. Thus, aninset with respect to the distal tip 29 is formed by this structure. Thelumen 28 extends into the inset segment 32 and is communicativelyconnected to an orifice 33, which is disposed in the side wall of theinset segment 32. The orifice 33 is shown to have a circularconfiguration.

Referring to FIGS. 1 A and B, the balloon 34 is disposed about the insetsegment 32. In an uninflated state, the balloon 34 has a tubularconfiguration and is sealingly secured at each of its ends to respectiveends 30 and 31 of the inset segment 32. Sealing securement may be madeby various methods, including adhesives, ultrasonic welding, andcompression fitting. The uninflated diameter of the balloon 34 is suchthat it is disposed substantially within the recess space formed by thedifference in diameter of the inset segment 32 and the distal tip 29.This provides a low profile device diameter which reduces vasculartrauma and puncture site diameter upon removal. In an inflated state theballoon 34 preferably assumes a rounded configuration, for exampleelliptical with a minimum inflated diameter of two times the french sizeof the introducer sheath puncture hole being sealed. In addition, theheight or thickness of the inflated balloon 34 is preferably less thanone half the diameter of a typical blood vessel being sealed, so as tominimize obstruction of flow through the blood vessel. The balloon 34 ispreferably constructed of an expandable material such as natural latex.

A flexible atraumatic extension 37 is shown disposed at the distal end12 of the vascular sealing device 10, extending from the inset segment32. The extension 37 preferably has a tubular structure with a diameterequivalent to that of distal tip 29. Importantly, the extension 37 isformed of a flexible material such as guidewire as known in the art. Theextension 37 is shown to have an end portion which is preferably curvedin its inoperative state. This structure decreases the level of traumato the vessel wall during insertion and manipulation of the device 10.

Referring to FIG. 1, 81 refers to a distance marker upon body 15 for thepurpose of indicating to the user that the balloon 34 is distal to thesheath taper end 48 shown in FIGS. 2 and 3. By alignment of marker 81 atthe top of the hemostatic valve opening at cap 45, proper location ofthe balloon 34 with respect to sheath tapered end 48 is assured.

Referring generally to FIGS. 2-5, in use, the vascular sealing device 10is inserted into the input end 45 of an introducer or vascular sheathdevice 43 which has been previously positioned within the lumen 58 of ablood vessel 56. The typical introducer 43, as is well known, comprisesa body structure 46, an elongated sheath 47 with a tapered end 48, ahemostatic ingress/egress valve 80 within a cap 45, an auxiliary tube 44and a suture connector 49 which may be used to maintain the introducer43 in an operative position on the patient's skin surface 55 forprolonged periods of time and to thereby permit reaccess to the patientsvascular system 56. The body 46 of the introducer 43 remains on theexterior of the patient's body at all times, while the sheath 47 extendsthrough puncture 60 in the skin surface 55, tissue 59, and vessel wall57.

The vascular sealing device 10 is first inserted through the valve orgasket 80 of the introducer 43, distal end 12 first, and is advanced byphysician manipulation of the body member 15, primarily, until thedistal end 12 extends just beyond the distal tapered tip 48 of thesheath 47. Next, an inflator such as a syringe (not shown) pierces theinflation/deflation port 14 of device 10. Fluid or gas is advanced intothe device 10 until a predetermined amount of balloon 34 inflation isattained. Then, the inflating means is removed. Next, the inflatedballoon section 34 is pulled up against the vessel wall 56 at thepuncture site 60, by manipulating the body member 15. At this point inthe procedure, a hemostatic seal is effected at the puncture site 60.Next, and importantly, a procoagulant is injected through a fluid accessport 44 of the introducer 43 and is released out its distal end 48 atthe puncture site 60. Next, the introducer sheath 47 is withdrawn bymanipulation of the introducer body 46 and sheath 47 proximal end. Theballoon section 34 remains abutted against the inner intraluminalsurface 56 of the puncture site 60. After a predetermined time period,on the order of 1-3 minutes, the balloon 34 is deflated and the device10 is pulled proximally out of the puncture site 60.

The procoagulant may include one of the following substances orcombinations of substances: (1) thrombin, (2) collagen, (3)fibrin/fibrinogen, (4) cyanoacrylate, (5) thrombin and collagen, (6)fibrin/fibrinogen and collagen, (7) cyanoacrylate and collagen, and (8)thrombin and fibrin/fibrinogen.

The advantages of the device 10 and method of the present inventioninclude, but are not limited to, both individually and cooperatively,(1) that the inflated balloon 34 blocks egress of blood immediately uponbeing properly positioned in the blood vessel at the puncture site toprovide fast hemostasis; (2) that the inflated balloon 34 acts as aninternal marker to permit the user to accurately gauge the depth of thepuncture and the thickness of the tissues surrounding the puncture; and(3) that the inflated balloon 34 acts as a backstop at the inner wall ofthe blood vessel to (i) precisely position the sealing clot in thepuncture and (ii) to prevent procoagulant from entering the patient'scirculatory system.

The descriptions above and the accompanying drawings should beinterpreted in the illustrative and not the limited sense. While theinvention has been disclosed in connection with the preferred embodimentor embodiments thereof, it should be understood that there may be otherembodiments which fall within the scope of the invention as defined bythe following claims. Where a claim is expressed as a means or step forperforming a specified function it is intended that such claim beconstrued to cover the corresponding structure, material, or actsdescribed in the specification and equivalents thereof, including bothstructural equivalents and equivalent structures.

The invention claimed is:
 1. A method for closing of an aperture in apatient's blood vessel through an introducer predisposed in the bloodvessel aperture, the introducer being of a type having an axial lumenopening to a distal insertion end adapted for location in the bloodvessel aperture, and a fluid injection port being communicativelyconnected to the introducer lumen; comprising the steps of:a. providinga medical sealing apparatus, comprising:i. a thin, elongated conduithaving a central lumen, said conduit having proximal and distal ends,said conduit distal end being insertable into the patient body apertureand having an inflation segment including an external orifice which iscommunicatively connected to said lumen; ii. an expandable membersealingly disposed at said conduit distal end inflation segment, saidexpandable member being inflatable to a predetermined diameter; and iii.means to connect said conduit lumen to an external inflation source,said means to connect being disposed at said proximal end of saidconduit; b. inserting said apparatus through the introducer lumen andinto the blood vessel aperture, said apparatus conduit being extendedthrough said introducer lumen so that said apparatus expandable memberis disposed outwardly beyond said introducer distal insertion end; c.inflating said expandable member; d. moving said expandable member intocontact with the blood vessel aperture; and e. introducing procoagulantinto said introducer lumen via said fluid injection port anddistributing said procoagulant out said distal insertion end.
 2. Themethod of claim 1, comprising the further step of deflating saidexpandable member.
 3. The method of claim 2, wherein said deflation iseffected within about 1 minute after moving said expandable member intocontact with the blood vessel aperture.
 4. The method of claim 2,wherein said deflation is effected within a time period of between aboutone and three minutes.
 5. The method of claim 1, wherein said conduithas a predetermined outside diameter and length, and is constructed of ametallic material having a predetermined degree of rigidity.
 6. Themethod of claim 5, wherein said conduit comprises hypotubing.
 7. Themethod of claim 1, wherein said conduit has a predetermined outsidediameter and length, and is constructed of a polymeric material having apredetermined degree of rigidity.
 8. The method of claim 1, wherein saidinflation segment is a hollow tubular structure extending coaxially fromsaid conduit distal end and having a predetermined outside diameterwhich is not greater than the diameter of said conduit at said distalend thereof, and a predetermined length, and wherein said central lumenis coextensive with said inflation segment.
 9. The method of claim 8,wherein said conduit and said inflation segment comprise a unitarystructure constructed of a homogeneous substance.
 10. The method ofclaim 8 wherein said inflation segment comprises an atraumatic extensiondisposed at an outward end of said segment, opposite its point ofconnection with said conduit, said atraumatic extension beingconstructed of a flexible material.
 11. The method of claim 10, whereinsaid conduit, said inflation segment, and said atraumatic extensioncomprise a unitary structure constructed of a homogeneous substance. 12.The method of claim 1, wherein said expandable member has a tubularconfiguration in an uninflated state with a tube wall and opposing tubeends, said tube ends being sealingly secured to said inflation segment.13. The method of claim 12, wherein said expandable member has a roundedconfiguration in an inflated state.
 14. The method of claim 12, whereinsaid expandable member is a pneumatic member which is inflatable via agas.
 15. The method of claim 12, wherein said expandable member is ahydraulic member which is inflatable via a liquid.
 16. The method ofclaim 12, wherein said expandable member has a diameter greater than thesize of the patient body aperture which is being sealed.
 17. The methodof claim 1, wherein:i) said inflation segment is coaxially disposed fromsaid conduit distal end, and wherein said central lumen is coextensivewith said extension member; ii) said expandable member has a tubularconfiguration in an uninflated state with a tube wall and opposing tubeends, said tube ends being sealingly secured to said inflation segment;and iii) said expandable member has a rounded configuration in aninflated state.
 18. The method of claim 1, wherein said connection meanscomprises an elastomeric sealing member.
 19. The method of claim 18,wherein said elastomeric sealing member comprises an elastomeric packingdisposed in said conduit central lumen at said proximal end thereof. 20.The method of claim 1, wherein said procoagulant is released at saidblood vessel aperture at a point proximally located with respect to saidexpandable member.